16 results · 23ms · Sources: EU EUDAMED, US FDA

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ISS-JAZZ Screw System and JAZZ CAP SP

FDA 510(k)
FDA Class 2 ·Orthopedic

Oticon

FDA UDI
Oticon A/S·05707131331595·OPN 3, KIT 13 2.4G NFM R C001

PROTRON TECHNOLOGIES, LLC STETHOTRON

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIOPSY HANDY, MRI BIOPSY HANDY

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·June 21, 2013

LIGAMAX 5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·October 3, 2008

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 28, 2011

MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

FDA Adverse Event
Injury ·COOK INC·Product code KRA·April 27, 2022

MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·April 11, 2022

MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·August 19, 2022

Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A

FDA Enforcement
Class II ·Ongoing·Sterilmed, Inc.·November 26, 2025

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024